Public and Private Interests in Animal Research

1. Public and Private Interests in Animal Research LAT Chapter 1

2. LAT Presentations Study Tips • If viewing this in PowerPoint, use the icon to run the show. • Mac users go to “Slide Show > View Show” in menu bar • Click on the Audio icon: when it appears on the left of the slide to hear the narration. • From “File > Print” in the menu bar, choose “notes pages”, “slides 3 per page” or “outline view” for taking notes as you listen and watch the presentation. • Start your own notebook with a 3 ring binder, for later study!

3. Introduction • LAT certification program allow you to increase your knowledge in: • Diagnostics • Surgical management • Research methodology • Administrative duties • Laboratory animal technicians are involved in more technical aspects of animal research

4. Public and Private Interests • U.S. Government provides approximately two-thirds of research/development funds spent by college and universities • Grant applications used to request funds: • Detailed description of research goals • Scientific basis of study • Review of relevant literature and all procedures to be performed

5. Competitive Federal Grant • Federal grant programs • NIH & NSF: Main public granting agencies for biomedical research • NIH: primary granting agency: academia, federal agencies, biomedical research • NSF: funds basic research in math, medicine, biology, etc. • Others: “mission agencies” • Departments of Defense, Energy, Agriculture, NASA • Private funding of research • Pharmaceutical companies , non-profit organizations

6. Legislation & Guidelines • USDA • Enforces and amends the AWA • Auction, sale, exhibit, transport, breeding or conduct of research with animals • Animals exempt from AWA: cold-blooded species, birds, mice, rats, and farm animals used for food, fiber, and nutrition • Research institutions must register with USDA • Supply annual reports • Inspection records are available to public via Freedom of Information Act (FOIA) • Unscheduled inspection once per year

7. Legislation & Guidelines http://www.nal.usda.gov/awic/legislat/regsqa.htm

8. Legislation & Guidelines • Public Health Service (PHS) Policy • Institutions which receive funding from PHS & NIH must follow these guidelines. • Requires filing of an Animal Welfare Assurance document that demonstrates that your institution is following the Guide, PHS policy, AWA, and any other applicable laws.

9. The Guide • Guide for the Care andUse of Laboratory Animals • Provides basic information on animal use for researchers • “Gold Standard” for institutions to model their animal care programs • AAALAC, International uses the Guide to evaluate and accredit animal care programs. • AAALAC accreditation is a voluntary process for animal care and use programs.

10. The Guide • Specific segments of the Guide include: • Institutional policies and responsibilities • Describes necessary compliance requirements • Laboratory animal management • Focuses on recommended cage sizes and construction requirements • Also covers recommended equipment, food, bedding, etc. • Veterinary medical care • Outlines major considerations related to animal selection, procurement, and health maintenance • Physical plant • Emphasizes proper construction of an animal facility

11. FDA & GLP Food and Drug Administration (FDA) • Assures that new drugs and medical devices are safe and effective before approved for use in humans • Monitors drugs after approval • Includes human and veterinary drugs, food, and medical devices • Requires that effectiveness be demonstrated through well controlled investigations Good Laboratory Practices (GLP) • Established in 1978 with implementation of laboratory audits and inspection program • Details requirements for QA and SOPs

12. FDA & GLP http://www.fda.gov/cder/about/history/default.htm

13. Importation and Transportation Regulations • For protection of humans and environment from potential disease carrying organisms • Several agencies control importation: • CDC • USDA • US Fish & Wildlife Service • Most states also have anti-cruelty laws

14. Institutional Guidelines • Policies established for: • facility operations • care and use procedures • veterinary support • physical plant • Standard operating procedures relate to: • all aspects of animal care and support • personnel management • health surveillance of animals and personnel • equipment • investigators • Technicians must have thorough knowledge of proper animal and facility maintenance.

15. IACUCs • IACUCs are mandated by AWA, PHS • policy, and the Guide. • IACUC functions include: • Review and approve protocols for animal use • Review animal use program and perform animal facilities inspections at least every 6 months • IACUC members include: • Veterinarian with experience in LA • Scientist who using research animal • Non-scientist • Person not affiliated with the institution

16. Animal Use Protocol Reviews • Animal care and use protocols • Principal Investigator provideswritten details of how animals will be used in the research project. • IACUC must review all protocols using animals. • IACUC must approve all protocols before any animal research can begin. • IACUC: • Can deny permission to start a project • Can stop a research project • Ensures compliance with regulations • Reviews complete protocols at least every 3 years; reviews updates to protocols yearly

17. Inspections & Program Review • Use The Guide as basis for inspection • Inspection performed by the IACUC members • Inspections performed every 6 months • Report issued to Institutional Official • Reports available to outside inspectors (USDA, AAALAC)

18. AAALAC, International • Association for Assessment and Accreditation of Laboratory Animal Care, International • Non-profit organization that provides a mechanism for peer review of animal care and use programs by scientific community • Detailed application with information on facilities, procedures, programs, and research animal use • Annual report must be submitted to AAALAC on status of animal care program • Site inspection and program evaluation every 3 years • Institutional goal = full accreditation

19. AAALAC, International http://www.aaalac.org/